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Neoadjuvant Therapy With Docetaxel and Ketoconazole in Patients With High-Risk Prostate Cancer: A Pilot Study

NCT00870714 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2009-03-27

No results posted yet for this study

Summary

Eligible patients with high-risk prostate cancer who are scheduled to undergo radical prostatectomy will receive four cycles of therapy with ketoconazole and docetaxel prior to surgery resection. A cycle of therapy is defined as 21 days (three weeks). Pharmacokinetic analysis will be performed with the first and second cycle of therapy. All patients will be evaluated for toxicity, tumor response, and recurrence.

Conditions

Interventions

DRUG

Docetaxel

Docetaxel 55mg/m2 to be given IV as a one-hour infusion to be repeated every 21 days for four treatment cycles.

DRUG

Ketoconazole

Ketoconazole 400mg P.O. BID daily to start on day 2 following the first docetaxel treatment. In patients who experience no grade 2 or higher toxicity, the ketoconazole dose will be increased to 400mg TID on day 2 following cycle #2 of docetaxel. This will be continued daily until completion of study treatment.

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Kansas City Veteran Affairs Medical Center

    lead FED

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2010-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00870714 on ClinicalTrials.gov